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Comparing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint for Trigger Finger

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ClinicalTrials.gov Identifier: NCT05763017
Recruitment Status : Recruiting
First Posted : March 10, 2023
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
National University of Malaysia

Study Description
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Brief Summary:
The purpose of this study is to compare the effectiveness of relative motion splint and metacarpophalangeal joint blocking splints in terms of sign and symptoms, hand function, occupational performance, and perception of splint wearability (comfort and satisfaction) after six weeks of TF management.

Condition or disease Intervention/treatment Phase
Trigger Finger Stenosing Tenosynovitis Other: Relative Motion Splint Other: Metacarpophalangeal Joint Blocking Splint Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparative Trial of Relative Motion Splint Versus Metacarpophalangeal Joint Blocking Splint in the Management of Trigger Finger
Actual Study Start Date : June 28, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Relative Motion Splint
In the relative motion splint, the metacarpophalangeal joint of the affected finger(s) positioned in approximately 20°-25° more extension/flexion than metacarpophalangeal joint of the adjacent fingers.
 Other: Relative Motion Splint
Six weeks relative motion splint wear.
Active Comparator: Metacarpophalangeal Joint Blocking Splint
In the metacarpophalangeal joint blocking splint, the metacarpophalangeal joint of the affected finger(s) positioned in 0°.
 Other: Metacarpophalangeal Joint Blocking Splint
Six weeks metacarpophalangeal joint blocking splint wear.


Outcome Measures
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Primary Outcome Measures :
  1. Stages of Stenosing Tenosynovitis (SST) [ Time Frame: Baseline, 6 weeks after splint wear ]
    SST is a grading system that divides trigger finger into six stages. Stage 1 is normal; Stage 2 is uneven finger movement; Stage 3 is triggering or clicking or catching; Stage 4 is locking of finger in flexion or extension, which can be unlocked by active finger movement; Stage 5 is locking of finger in flexion or extension, which requires application of passive force to unlock; and Stage 6 is locked finger in flexion or extension


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) for pain [ Time Frame: Baseline, 6 weeks after splint wear ]
    The left end of the VAS labelled as "no pain" and the right end labelled as "extreme pain".

  2. Number of triggering events in ten active fists [ Time Frame: Baseline, 6 weeks after splint wear ]
    The number of triggering events (0 - 10) can be obtained by asking the patient to make 10 active full fists.

  3. Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure [ Time Frame: Baseline, 6 weeks after splint wear ]
    DASH is a 30-item, self-report questionnaire that range from 0-100 score, with higher scores represent more severe disability or poorer hand function.

  4. Canadian Occupational Performance Measure (COPM) [ Time Frame: Baseline, 6 weeks after splint wear ]
    COPM is a interview-based assessment tool for measuring occupational performance. The importance, satisfaction, and performance of an activity are rated using a 10-point rating scale.

  5. Visual Analog Scale (VAS) for splint comfort [ Time Frame: Baseline, 3 and 6 weeks after splint wear ]
    The left end of the VAS labelled as "not at all comfortable' and the right end labelled as "extremely comfortable".

  6. Visual Analog Scale (VAS) for splint satisfaction [ Time Frame: Baseline, 3 and 6 weeks after splint wear ]
    The left end of the VAS labelled as "not at all satisfied" and the right end labelled as "extremely satisfied".


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • single or multiple trigger finger
  • unilateral or bilateral trigger finger
  • neutral metacarpophalangeal joint position can be attained during passive isolated metacarpophalangeal joint extension of the affected finger

Exclusion Criteria:

  • trigger thumb
  • steroid injection of the affected finger within last six months
  • A1 pulley release of the affected finger.
  • history of fracture, tendon injury, nerve injury, Dupuytren's contracture, and other soft tissue injuries of the affected finger or adjacent fingers.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05763017


Contacts
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Contact: Li Xian Leong, BSc (OT) +609-295 5333 lixianmetta@gmail.com

Locations
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Malaysia
Hospital Sultan Haji Ahmad Shah Recruiting
Temerluh, Pahang, Malaysia, 28000
Contact: Li Xian Leong, BSc (OT)       lixianmetta@gmail.com   
Sponsors and Collaborators
National University of Malaysia
Investigators
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Principal Investigator: Siaw Chui Chai, PhD (OT) Occupational Therapy Programme, Center for Rehabilitation & Special Needs Studies (iCaRehab)
More Information
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Responsible Party: National University of Malaysia
ClinicalTrials.gov Identifier: NCT05763017    
Other Study ID Numbers: JEP-2022-319
First Posted: March 10, 2023    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National University of Malaysia:
relative motion splint
metacarpophalangeal joint blocking splint
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tenosynovitis
Tendon Entrapment
 Tendinopathy
Muscular Diseases
Musculoskeletal Diseases